De novo AML patients with favourable-intermediate karyotype may benefit from the addition of low-dose gemtuzumab ozogamicin (GO) to fludarabine, Ara-C and idarubicin (FLAI): A contribution to the reopened "gO question"

Marino Clavio, Fabio Cruciani, Paola Minetto, Fabio Guolo, Filippo Ballerini, Carlo Marani, Enrico De Astis, Sara Aquino, Micaela Bergamaschi, Laura Mitscheunig, Raffaella Grasso, Nicoletta Colombo, Chiara Ghiggi, Davide Lovera, Giordana Pastori, Daniele Avenoso, Maurizio Miglino, Marco Gobbi

Research output: Contribution to journalArticle

Abstract

We report the final results of a prospective trial testing the combination of fludarabine, Ara-C and idarubicin (FLAI) followed by low-dose gemtuzumab ozogamicin (FLAI-GO) in 85 patients aged 60 years or more with CD33+ acute myeloid leukaemia (AML). Median age was 68 years (60-82); karyotype was unfavourable in 21 patients (24 %), intermediate in 63 (74 %) and favourable in 1 (2 %). There were five therapy-related deaths. Of the 80 evaluable patients, 47 achieved complete response (CR) (58 %); CR rates were 65 and 32 % in good-intermediate/poor karyotype patients, respectively. Median length of CR was 7 months (3-76). The cumulative incidence of relapse was 84 % with an actuarial survival of 50.3 % at 1 year and 14.4 % at 2 years. The study control population is an unselected consecutive historic cohort of 104 patients treated with the FLAI regimen, who were matched for age and prognostic factors. CR rates after FLAI-GO and FLAI were comparable. However, patients with de novo AML and intermediate-favourable karyotype receiving GO had a significantly lower risk of relapse at 2 years as compared to patients not receiving GO (n = 77) (40 vs 80 %, p = 0.01) and significantly better disease-free survival (p = 0.018) and overall survival (p = 0.022).

Original languageEnglish
Pages (from-to)1309-1318
Number of pages10
JournalAnnals of Hematology
Volume92
Issue number10
DOIs
Publication statusPublished - Oct 2013

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Keywords

  • AML
  • Ara-C
  • Fludarabine
  • Gemtuzumab ozogamicin
  • Idarubicin

ASJC Scopus subject areas

  • Hematology

Cite this

Clavio, M., Cruciani, F., Minetto, P., Guolo, F., Ballerini, F., Marani, C., De Astis, E., Aquino, S., Bergamaschi, M., Mitscheunig, L., Grasso, R., Colombo, N., Ghiggi, C., Lovera, D., Pastori, G., Avenoso, D., Miglino, M., & Gobbi, M. (2013). De novo AML patients with favourable-intermediate karyotype may benefit from the addition of low-dose gemtuzumab ozogamicin (GO) to fludarabine, Ara-C and idarubicin (FLAI): A contribution to the reopened "gO question". Annals of Hematology, 92(10), 1309-1318. https://doi.org/10.1007/s00277-013-1780-7